Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (NCT06257537) | Clinical Trial Compass
RecruitingPhase 2
Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
United States300 participantsStarted 2024-10-01
Plain-language summary
The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period.
The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain.
Secondary objectives are to assess the ability of LITUS to improve joint function.
Who can participate
Age range50 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* Are between 50-85 years of age
* Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
* Report that knee pain negatively affects quality of life
* Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
* Are deemed appropriate by their physician or by the study site physician to participate.
* Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
* Not use or initiate use of opioid and/or non-opioid analgesic medications.
* Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Exclusion Criteria:
* Cannot successfully demonstrate the ability to put on and take off the device.
* Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow …
What they're measuring
1
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Timeframe: Through study completion, average of 24 weeks.
2
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: Through study completion, average of 24 weeks.